MAUDE Adverse Event Report: US ENDOSCOPY PADLOCK CLIP; PADLOCK CLIP STANDARD

Model Number	C910001
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The padlock clip is used to clip placement within the gastrointestinal tract and consists of a single-use clip within a delivery system.The clip component of the device is within a delivery housing with is mounted and secured at the distal tip on the outside surface of a flexible endoscope.A linking cable rests along the outside of the endoscope's insertion tube and connects the delivery housing/clip to a control handle and thumb actuator.The user facility returned the device subject of the reported event to steris for evaluation.The evaluation determined the linking cable was disconnected from the control handle and had multiple kinks.Based on the evaluation results, the reported event was likely caused by the disconnected linking cable which is part of the mechanism to deploy the clip.The damage observed to the linking cable is indicative of improper handling by user facility personnel.The padlock clip standard instructions for use states, "check to ensure that the scope is inserted completely into the scope mounting feature of the delivery housing and that the housing isn't expanded.Too tight of a fit can expand the scope mounting feature making the pushing mechanism sluggish and allow the padlock clip® to get hung up on deployment, especially in retroflexion.If any clip points extend beyond distal rim/edge, carefully replace safety cap, do not use this product, contact your local product specialist or customer service representative, and use a different device for procedure.Do not remove the handle stay until endoscope with loaded padlock clip® defect closure system is in position over defect and ready for deployment.Avoid bending the linking cable too aggressively or using a grasping/clamping device on the linking cable as it can create a "kink" and/or disable device function.Deploy padlock clip® by using a firm and rapid thrust of the thumb actuator while holding the control handle body.Once the handle stay is removed, keep hands and fingers clear from the delivery housing distal tip so that an accidental release of the padlock clip® does not result in personal injury.Once the handle stay is removed, use caution in handling thumb actuator button to prevent inadvertent deployment of the clip.When using suction to pull target tissue into the cap, there is a risk of capturing tissue/organs outside of the lumen and adjacent to the target treatment area.Use of a grasping device is recommended to acquire the target tissue and minimize the risk of capturing tissue/ organs adjacent to the treatment area." the device history record for the subject lot was reviewed and confirmed the lot was manufactured according to specifications; no abnormalities were noted.Steris offered in-service training on the proper use and operation of the padlock clip standard; however, the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported during a patient procedure the padlock clip standard did not deploy the clip.A second padlock clip standard was used to complete the procedure resulting in a procedure delay.No report of injury.

• Brand Name: PADLOCK CLIP
• Common Device Name: PADLOCK CLIP STANDARD
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5976 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24965016
• Report Number: 1528319-2026-00036
• Device Sequence Number: 10455405
• Product Code: PKL
• UDI-Device Identifier: 00724995184247
• UDI-Public: (01)00724995184247(11)251105(17)281105(10)13085087
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: C910001
• Device Catalogue Number: C910001
• Device Lot Number: (10)13085087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown